Director, Regulatory Affairs

Veristat; North Carolina; On-site; USD 195,000 - 223,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat seeks a Director of Regulatory Affairs to lead strategic regulatory consulting for client programs from early development through NDA/BLA. You will prepare pivotal documents, interact with FDA and health authorities, and guide cross-functional teams.

The role combines regulatory leadership with client-facing BD responsibilities in a global setting. Ideal candidates have a decade in CRO/pharma, five years leading regulatory projects, and strong proficiency in ICH-GCP, writing, and

Qualifications

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field.
• Advanced scientific degree (Master’s, Ph.D. or Pharm.D.) preferred with applied training relevant to clinical trials.
• 10 years of relevant CRO/pharma experience, including at least 5 years leading regulatory development projects.
• Thorough knowledge of ICH GCP guidelines and other regulatory rules and guidelines.
• Excellent written and oral communication, including technical writing skills.

Responsibilities

• Provide strategic regulatory consulting from early development through NDA/BLA.
• Independently prepare regulatory documents such as US IND, NDA/BLA modules, ODD, and Fast Track designations.
• Interact with clients, FDA, and health authorities as main contact.
• Lead cross-functional scientific interactions and contribute to internal BD and marketing.
• Support business development and regulatory strategy across client programs.

Skills

Regulatory leadership

Regulatory development

GxP/ICH-GCP knowledge

Communication skills

Team leadership

Microsoft Word/Excel

Education

Bachelor's degree in science or related field

Advanced scientific degree (MS/PhD/Pharm.D.)

Tools

Microsoft Word

Microsoft Excel

Job description

Responsibilities

Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA will be client facing and will be responsible amongst others for:

• Strategic Advice to clients, with focus on early development through to NDA/ BLA
• Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests.
• Scientific Interaction with internal cross functional teams
• Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities
• Internal BD & marketing facing role

Job Description

Director, Regulatory Affairs

Responsibilities

Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA will be client facing and will be responsible amongst others for:

• Strategic Advice to clients, with focus on early development through to NDA/ BLA
• Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests.
• Scientific Interaction with internal cross functional teams
• Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities
• Internal BD & marketing facing role

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Learn more about our core values here!

What We Offer

• The estimated hiring range for this role is $195K-223K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
• Benefits vary by location and may include:
• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What We Look For

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials.
• 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 5 years of experience leading regulatory development projects.
• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Excellent written and oral communication skills including grammatical and technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required.
• In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
• Demonstrated ability to lead by example with demonstrated skill for technical and supervisory leadership of staff.
• Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.